Per the New York Times, the President’s Council on Bioethics has been given its walking papers.  Although the Council’s authority was set to expire September 30, it has been asked to cancel its June meeting, and the members have been told their services are no longer needed.  I have found no indication that the naming of a new council is imminent, but it stands to reason that it should happen soon, at least prior to September 30.

The New York Times article notes that

“The council was disbanded because it was designed by the Bush administration to be “a philosophically leaning advisory group” that favored discussion over developing a shared consensus, said Reid Cherlin, a White House press officer.

“President Obama will appoint a new bioethics commission, one with a new mandate and that “offers practical policy options,” Mr. Cherlin said.”

Aside from the stem cell decision made by President Bush early in his administration, there have been few, if any, policy judgments made that received recommendations from the council.  It has issued several reports on various biomedical issues, but they were often readers on the subject, essay collections, or other documents more suited for background information than policy advice.  This is, of course, the perogative of the President.

Picking up on a post from last month, ScienceInsider and others have reported on a lawsuit that may test the validity of gene patents.  The Public Patent Foundation and the American Civil Liberties Union have filed suit against Myriad Genetics, which is the company owning the patents, and controlling the genetic tests, for the BRCA1 and BRCA2 genes that show a predisposition to breast cancer.  Among the allegations is that the monopoly on these genes and the associated diagnostic tests prevents patients from obtaining a second opinion.  Apparently any examination of these genes requires permission from Myriad Genetics, which seems like an overreach of the traditional conception of the protection afforded patent holders.  The consequences to individuals include the inability to have other scientists assess the results of the tests and the influence of these genes on the potential for cancer.  General effects include a chill on research into these genes, and other consequences addressed by Nobel laureate in Physiology or Medicine Sir John Sulston.

It’s unfortunate that the validity of gene patents is going to be tested in this fashion, as I don’t expect this validity to be shaken.  Perhaps it’s a consequence of the deep pockets necessary to participate in a patent infringement case (on either side), but I think some kind of fair use or research exemption arrived at through an infringment action is a stronger legal claim than infringement of free speech.  Since the state of genetic understanding over the last several years has typically exposed more about what we don’t know that what we do know, to restrict access to genes like BRCA1 and BRCA2 appears to cause more harm than good.

On Friday the National Institutes of Health issued draft guidelines for funding research on stem cells.  This guidelines are in response to the March Executive Order issued by President Obama revising the previous funding constraints on stem cell research.  The guidelines are for extramural research, as internal NIH procedures cover all intramural research.

As is all too common with this issue, things get blurred pretty quickly.  This funding and associated guidelines are for research conducted on the stem cells, and cannot fund the derivation of human embryos.  The Dickey-Wicker Amendment bans such derivation.  The guidelines also restrict NIH funding to embryonic stem cells derived from embryos created for reproductive purposes that would otherwise be discarded.  Research on adult stem cells and induced pluripotent stem cells can *continue* to be funded by NIH dollars.  As it stands, this is not a free-for-all.  From the announcement of the draft guidelines:

NIH funding for research using human embryonic stem cells derived from other sources, including somatic cell nuclear transfer, parthenogenesis, and/or IVF embryos created for research purposes, is not allowed under these Guidelines.

As I noted, these are draft guidelines, and comments can be submitted to NIH.  The comment period is 30 days from the publication of a notice of rulemaking in the Federal Register, which should happen this week.  Check back to the NIH link I provided above to find the final date for comments, which should be no later than May 24, along with more specifics about how and where to send your comments.

A recent federal appeals court ruling (H/T Science Insider) determined that DNA obtained from a known protein cannot be patented.  Contrary to my first impulse, the U.S. Patent and Trademark Office (USPTO) had denied the patent and the petitioners appealed.  While I am hoping this slows down a trend of patenting everything under the sun, primarily as a defensive measure, reading the opinion suggests that USPTO just plain dropped the ball here.  However, this does mean that some researchers are inclined to just apply for patents, and hope that things stick.  Given the perpetual backload of the USPTO, some stuff will slip through the cracks that probably shouldn’t.

In the area of research, patenting items, whether they are gene sequences, research instruments, or life forms, is a double-edged sword.  While it makes sense to allow the limited property right of a patent to help recover some of the expense involved in developing the innovation, a patent barrier can chill research in various areas.  When looking at lab equipment, it’s unclear to me whether or not strictly enforcing the intellectual property on a new device pushes forward the leading edge of research.  Labs have plenty of associated costs as it is, and aggressive patent enforcement runs the risk of putting labs out of business.  Yes, research is expensive, but not all of the expenses are necessarily justified.

In what might be a mix of a slow news day and the “War on Science” mentality, several science sites are reporting on a statement made criticizing President Obama’s recent stem cell research decision.  The statement was released by the Hastings Center and authored by several members of the President’s Council on Bioethics.  There is no mention of the statement on the Council’s website, and language in the statement suggests (though it could be stronger) that it is not an official Council statement.  Part of why some think this is newsworthy is that the Council is still operative until later in the year.  It is advisory, so it can do nothing binding on the Administration (or its predecessor).

Even so, it looks odd to the casual observer to have members of a Presidential Council opposing a President.  Therefore, much rending of garments and gnashing of teeth by those seeking to fill column inches or RSS feeds.  The problem is that the writing of the documents and especially the headlines perpetuates falsehoods about what happened.  It is not an official council statement, yet two of the headlines reporting the statement suggest that it is.  Now who’s pulling a bait and switch?

Today, Obama signed an executive order lifting Bush’s ban on the use of federal funds for stem cell research, along with a memo addressing the general issue of scientific integrity in executive branch agencies. Here’s an excerpt from the memo:

The public must be able to trust the science and scientific process informing public policy decisions.  Political officials should not suppress or alter scientific or technological findings and conclusions.  If scientific and technological information is developed and used by the Federal Government, it should ordinarily be made available to the public.  To the extent permitted by law, there should be transparency in the preparation, identification, and use of scientific and technological information in policymaking.  The selection of scientists and technology professionals for positions in the executive branch should be based on their scientific and technological knowledge, credentials, experience, and integrity.

For many, this is not just about opening the door to a particular kind of medical research; they view it as a fundamental change in the role played by science in policy.

This seems to emerge in the media coverage of the event. There is considerable discrepancy between the actual contents of the memo, and what the media (and those they interview) have been saying about it. For example, on NPR:

DeGette says that during the Bush administration, scientific policy was often dictated by things other than scientific evidence.

Well, yes, of course it was. As is often said on this blog, policy is never dictated by science, and Obama’s memo says nothing that would suggest otherwise. It is very much focused on process and openness, but makes no statements about how science should influence decision making.

The Washington Post quotes Harold Varmus (former NIH director, Nobel laureate, and Obama advisor):

Today’s executive order “is consistent with the president’s determination to use sound scientific practice . . . instead of dogma in developing federal policy”

This suggests that you can somehow use science instead of values to develop policy. But Obama’s stem cell decision is no less value driven than was George Bush’s. Regardless of your position, to come to a conclusion on the ethics of stem cell research you must wrestle with difficult issues such as the acceptability of destroying human embryos. Obama’s words and actions suggest nothing like the “determination” Varmus describes.

It’s important to remember that this event represents a political success — a shift away from one set of values, and toward another (though of course, it is not so black and white). It is not, by any means, a shift from politics toward science. Even if that were possible, it’s hard to see why it would be desirable.

The Washington Post reports in today’s edition that among the many changes in Executive Orders possible in the first days of the new administration could be an easing of the restrictions on stem cell research and permitting California to proceed with a waiver allowing the state to regulate carbon dioxide emissions.  Adjustments and revocations of Executive Orders are common during changes in administrations, and there are no doubt many signed by President Bush that would not sit well with the next President.

Many other possible changes, including some new proposals, are listed in the article, but the stem cell research restrictions and the California waiver issue are among the few that are either sourced by individuals willing to be named in the article, or connected to statements made by Senator Obama during the campaign.  Given the heavy message discipline of the campaign and of the transition so far, it is premature to assume anything is a certainty.  Additionally, as noted in the article, these decisions will involve consultations with relevant legislators and appointees, most of whom are not yet named.  Of course, you can go to the transition website and make your opinions heard.

Yes, I have the election on the brain, in part because I spent most of Monday night and all of Tuesday as a poll worker in Maryland.  While ScienceBlogs appears to think that the presidential results were a vote for science (whatever that means), there were many other races and referendums voted on yesterday.  I’ve not yet drilled down through all of the state races, but I have noticed a stem cell research resolution was narrowly approved in Michigan yesterday.  Per this Associated Press article, the measure allows for stem cell research to be conducted on embryos created for fertility treatments but donated for research purposes.  The current stem cell research policy allows such research only on those stem cell lines created in other states.

Presumably part of the intended purpose of this initiative is to circumvent both current state policy and federal policy, which limits federal support to those lines already existing at the time the policy was initiated in 2001.  At least seven other states have established state stem cell research institutes, and perhaps Michigan will follow suit.

I will keep looking for other science and technology related measures approved (or rejected) in this recent election, but readers should feel free to post any examples from this election in the comments.

The Personal Genome Project is looking for a few thousand people willing to contribute their genome to help make personal genome sequencing more accessible and affordable.  The Washington Post recently reported on the project, as did Wired.  I think collaborative experiments and research like this – which could engage with people who aren’t researchers just as easily as researchers – is a good thing and should be encouraged.  As the amount of data we can use to conduct research increases dramatically, collecting and analyzing it – at least in some disciplines – will benefit from the contributions of others – whether its spare cycles on their computer or individual data to help better understand population data.

The problem with the Post piece – which focused on the recent addition of several scientists personal genome data to the publicly available portion of the project – is that it glosses over the critical privacy concerns that must be part of any database that can be accessed by the public, especially those that contain medical information.  Contrary to what you might think from the article, people can participate in the program and limit the exposure of their personal genetic information.  Online does not automatically equal no privacy.  Arguments that suggest privacy no longer exists, or can no longer be preserved, are arguments from technological determinism – that there is nothing we can do about technology and its momentum. If that were true, the utility of technology policy would be next to nothing – something that doesn’t reflect reality.

An article came across one of my inboxes and grabbed my attention: apparently a genetically modified maize strain developed by Monsanto has shown some concerning tendencies to cause liver and kidney toxicity in rats fed the GM’d corn. (Can’t get the study online yet but it was published in Archives of Environmental Contamination and Toxicology.)

I guess this may be of concern because the maize has been approved for use and is being grown in seven countries and the EU? From what I can gather from the limited info available, to this point Monsanto has done all the safety studies on the strain, and despite some indications of problems (see here…warning, hard advocate site citing other hard advocate group, but you take what you can get) has declared its own product safe. The researchers of the new study say

“Our counter-evaluation show that there are signs of toxicity and that nobody can say scientifically and seriously that consumption of the transgenic maize MON863 is safe and good for health,” lead author of the study, Professor Gilles Eric Séralini told France’s TF1 television station.

You know what’s coming next, right? That’s right, Data Wars XXVI:

Monsanto France has rejected the concerns. Yann Fichet, Monsanto France’s director of external relations told TF1: “[MON863] has already been examined by competent authorities and scientific experts in more than 10 countries worldwide, including the European Union and France, and all the experts concluded unanimously that the maize in question is as safe as traditional maize.”

The problem for Monsanto is that the new study is published in a peer-reviewed journal, which gives it loads of legitimacy no matter what the author’s funding was (could be a national lab, could be Greenpeace, but I can’t read French so I don’t know). Further compounding their problem is the previous notice of a Monsanto study on this same strain, noting the liver and kidney issues (can you spell Vioxx?). However, I also get the feeling from a bit of googling on MON863 that the study author basically works for Greenpeace, so who knows where this is going to lead. Anybody who tracks the GMO policy game care to comment?